Nivolumab in Lung Cancer Shows 'Unprecedented' Survival

Medscape Medical News from the
American Society of Clinical Oncology (ASCO) 2015 Annual Meeting
Medscape Medical News > Conference News
Nivolumab in Lung Cancer Shows 'Unprecedented' Survival
Zosia Chustecka
May 29, 2015

CHICAGO, IL — The immunotherapy nivolumab (Opdivo, Bristol-Myers Squibb) has beaten chemotherapy in another subset of patients with lung cancer in the second phase 3 trial to show an improvement in survival compared with docetaxel.

The results were hailed as practice-changing here at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting.

Nivolumab is the new standard of care in patients with previously treated squamous nonsmall cell lung cancer (NSCLC), declared Roy Herbst, MD, PhD, chief of medical oncology at the Yale Cancer Center in New Haven, Connecticut, who acted as discussant for the study. Overall survival was significantly improved, and nivolumab showed significantly less toxicity than docetaxel, he said.

"We now need to move this to frontline therapy in lung cancer," Dr Herbst said.

The latest results come from the CheckMate 057 study, Results released today from the CheckMate 057 study, conducted in 582 patients with advanced nonsquamous NSCLCnonsmall cell lung cancer (NSCLC) who who had progressed on platinum-doublet chemotherapy, . The overall results show that treatment with nivolumab extended median overall survival by 3 months compared with docetaxel (12.2 vs 9.4 months; hazard ratio, 0.73; P = .00155).

However, a subset of patients with high levels of expression of programmed death ligand 1 (PDL-1) showed even great benefit; here the median overall survival was 17.2 to 19.4 months. This is unprecedented in this type of patient population, commented lead author Luis Paz-Ares MD, PhD, from the Hospital Universitario Virgen Del Roccio in Seville, Spain. Usually, patients who are treated with second-line docetaxel have a median overall survival of 8 to 10.4 months, he added.

He noted that although the responses and survival were much lower in the patients who had low PDL-1 expression, some of these patients did respond, so this biomarker is useful as a positive predictor of patients who are likely to respond, but not so useful as a negative predictor of those who are unlikely to respond.

In his discussion of the results, Dr Herbst said the PDL-I biomarker is not yet ready for clinical use.

Response rates were higher in the nivolumab group compared with in the docetaxel group (19.2% vs 12.4%). Responses also lasted significantly longer in the nivolumab group (17.1 vs 5.6 months, on average).

Dr Paz-Ares said he was hopeful that longer follow-up will show that the responses to immunotherapy in lung cancer are long-lasting, as they have shown to be in melanoma.

Already Approved for NSCLC

This is the second phase 3 trial to show a survival benefit with nivolumab. The other was CheckMate 017, which was conducted in patients with advanced squamous NSCLC. This trial has already resulted in the approval of nivolumab for squamous NSCLC in the United States; this indication was also recently recommended for approval in Europe.

These latest results should result in an approval for the nonsquamous subset of NSCLC as well, predicts Dr Paz-Ares. He noted that nonsquamous subset is the larger of the two, accounting for around 60% of all patients with lung cancer, whereas the squamous subset accounts for some 25%. The remainder is made up of SCLC, he commented, which is a different disease.